Portico Valve-in-Valve Retrospective Registry

Aortic Valve Stenosis Clinical Trial

Official title:

Retrospective Assessment of the Portico Transcatheter Aortic Valve for Valve-in-Valve Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05002088
• Other study ID #: ABBOTT-CIP-10414
• Status: Completed
• Start date: October 21, 2021
• Est. completion date: December 29, 2023

Study information

• Verified date: February 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The objective of this data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.

Description:

Two options currently exist to treat failed surgical aortic bioprostheses: transcatheter valve-in-valve implantation (ViV) or redo surgical aortic valve replacement (rAVR). The objective of this comprehensive data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 29, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject had a degenerated surgical aortic bioprosthetic valve with severe aortic stenosis, severe regurgitation, or a combination of at least moderate stenosis with at least moderate regurgitation per EAPCI-ESC-EACTS standardized criteria.

2. Surgical bioprosthesis true inner diameter (true ID) was = 19 mm and = 27 mm and was confirmed by either CT or confirmed by the Valve in Valve Aortic App. Refer to the PCR website https://www.pcronline.com/PCR-Publications/PCR-mobile-apps/Valve-in-Valve-Aortic-app Note: if CT was contraindicated and/or not possible to be obtained, a transesophageal echocardiogram (TEE) will be accepted for sizing.

3. Prior to Portico ViV procedure, the patient was deemed at increased risk for surgery to replace the surgical aortic bioprosthetic valve.

4. Subject provided written informed consent prior to performing data collection for study specific visits. For patients that are deceased at the time of enrollment, all institutional/local legal and regulatory requirements for consent must be met prior to enrollment and data collection.

5. Subject is = 18 years of age or legal age in host country at the time of consent.

6. Prior to the Portico ViV index procedure, the subject had New York Heart Association (NYHA) class II, III, or IV.

7. Subject had a minimum vessel diameter of 6.0 mm for Portico™ delivery system access or a minimum of 5.0 mm for the FlexNav™ delivery system.

8. Subject had the Portico or FlexNav delivery system enter their vasculature

Exclusion Criteria:

1. Subject had evidence of an acute MI, percutaneous intervention, or a peripheral intervention =30 days prior to Portico ViV index procedure (MI defined as: ST Segment Elevation as evidenced on 12 Lead ECG).

2. Subject had uncontrolled blood dyscrasias defined as: leukopenia (WBC<3,000 mm3), acute anemia (Hb <9 g/dL), or thrombocytopenia (platelet count <50,000 cells/mm³).

3. Subject was considered hemodynamically unstable at the time of the ViV procedure (requiring inotropic support or mechanical heart assistance)

4. Subject had severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram.

5. Subject had imaging evidence of intracardiac mass, thrombus or vegetation.

6. Subject had an active peptic ulcer or has/had upper gastrointestinal (GI) bleeding =3 months prior to ViV index procedure.

7. Subject had a documented history of a cerebrovascular accident (CVA) or a transient ischemic attack (TIA) =6 months prior to index procedure.

8. Subject had renal insufficiency (serum creatinine >3.0 mg/dL (265.5µmol/L)) and/or end stage renal disease requiring chronic dialysis.

9. Subject had active bacterial endocarditis or ongoing sepsis = 6 months prior to the index procedure.

10. Surgical aortic bioprosthetic valve was unstable or rocking.

11. Subject had a vascular condition (i.e. stenosis, tortuosity, or severe calcification) that made insertion and endovascular access to the aortic valve impossible.

12. Subject was unable to tolerate antiplatelet or anticoagulant therapy

Related Conditions & MeSH terms

• Aortic Insufficiency
• Aortic Stenosis
• Aortic Valve Failure
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement

Locations

Country	Name	City	State
Australia	GenesisCare - St Andrew's Hospital & GenesisCare Leabrook - Satellite Site of GenesisCare - Wesley Hospital	Adelaide
Australia	GenesisCare - Wesley Hospital	Auchenflower
Denmark	Rigshospitalet	Copenhagen
Germany	Kerckhoff-Klinik gGmbH	Bad Nauheim
Germany	Universitätsklinikum Rostock (AöR)	Rostock
United Kingdom	St. Bartholomew's Hospital	London
United Kingdom	Morriston Hospital - ABM University Health Board	Morriston

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Australia,  Denmark,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of all-cause mortality, disabling stroke, life-threatening bleeding requiring blood transfusion, acute kidney injury (AKI) requiring dialysis, and major vascular complication adverse events at 30-days post-procedure.	Composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury (AKI) requiring dialysis, and major vascular complications	30 days post index procedure
Primary	The rate of all-cause mortality and disabling stroke adverse events at 1-year post-procedure.	Composite of all-cause mortality or disabling stroke	1 year post index procedure
Secondary	Procedure Success (descriptive endpoint)	Defined as absence of procedural mortality AND successful access, delivery of the valve, and retrieval of the delivery system	Procedure
Secondary	Evaluation of adverse event rates (descriptive endpoint)	All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), New pacemaker implant (PPI), Coronary obstruction, Minor, Major, and life-threatening bleeding, major vascular, access-related, or cardiac structure complication, acute kidney injury (AKI) stages 1-4	30 days post index procedure
Secondary	Evaluation of adverse event rates (descriptive endpoint)	All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), New pacemaker implant (PPI), Coronary obstruction	1 year post index procedure
Secondary	Evaluation of adverse event rates (descriptive endpoint)	All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA	2 years post index procedure
Secondary	Evaluation of adverse event rates (descriptive endpoint)	All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA	3 years post index procedure
Secondary	Evaluation of adverse event rates (descriptive endpoint)	All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA	4 years post index procedure
Secondary	Evaluation of adverse event rates (descriptive endpoint)	All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA	5 years post index procedure
Secondary	Clinical Benefit Endpoint	Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years	30 days post index procedure
Secondary	Clinical Benefit Endpoint	Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years	1 year post index procedure
Secondary	Clinical Benefit Endpoint	Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years	2 years post index procedure
Secondary	Clinical Benefit Endpoint	Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years	3 years post index procedure
Secondary	Clinical Benefit Endpoint	Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years	4 years post index procedure
Secondary	Clinical Benefit Endpoint	Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years	5 years post index procedure